How do prescription and over-the-counter (OTC) medicine labels help my doctor choose the right medicine for me when I am pregnant?

Doctors use information from many sources when they choose medicine for a patient, including medicine labels. To help doctors, the FDA created pregnancy letter categories to help explain what is known about using medicine during pregnancy. This system assigns letter categories to all prescription medicines. The letter category is listed in the label of a prescription medicine. The label states whether studies were done in pregnant women or pregnant animals and if so, what happened. Over-the-counter (OTC) medicines do not have a pregnancy letter category. Some OTC medicines were prescription medicines first and used to have a letter category. Talk to your doctor and follow the instructions on the label before taking OTC medicines.

Prescription Medicines

The FDA chooses a medicine's letter category based on what is known about the medicine when used in pregnant women and animals.

Pregnancy Category

Definition

Examples of Drugs

A

In human studies, pregnant women used the medicine and their
babies did not have any problems related to the medicine.

In humans, there are no good studies. But in animal studies, pregnant animals received the medicine, and the babies did not show any problems related to the medicine.

Or

In animal studies, pregnant animals received the medicine, and some babies had problems. But in human studies, pregnant women used the medicine and their babies did not have any problems related to using the medicine.

In humans, there are no good studies. In animals, pregnant animals treated with the medicine had some babies with problems. However, sometimes the medicine may still help the human mothers and babies more than it might harm.

Or

No animal studies have been done, and there are no good studies in pregnant women.

Studies in humans and other reports show that when pregnant women use the medicine, some babies are born with problems related to the medicine. However, in some serious situations, the medicine may still help the mother and the baby more than it might harm.

Studies or reports in humans or animals show that mothers using the medicine during pregnancy may have babies with problems related to the medicine. There are no situations where the medicine can help the mother or baby enough to make the risk of problems worth it. These medicines should never be used by pregnant women.

The FDA is working hard to gather more knowledge about using medicine during pregnancy. The FDA is also trying to make medicine labels more helpful to doctors. Medicine label information for prescription medicines is now changing, and the pregnancy part of the label will change over the next few years.

OTC medicines

Keep in mind that other things like caffeine,
vitamins, and herbal remedies can affect the growing fetus. Talk with your doctor about cutting down on caffeine and ask which type of vitamin you should take. Never use an herbal product without talking to your doctor first.

All OTC medicines have a Drug Facts label. The Drug Facts label is arranged the same way on all OTC medicines. This makes information about using the medicine easier to find. One section of the Drug Facts label is for pregnant women. With OTC medicines, the label usually tells a pregnant woman to speak with her doctor before using the medicine. Some OTC medicines are known to cause certain problems in pregnancy. The labels for these medicines give pregnant women facts about why and when they should not use the medicine. Here are some examples:

Nonsteroidal anti-inflammatory drugs (NSAIDs) like
ibuprofen (Advil®, Motrin®),
naproxen (Aleve®), and
aspirin (acetylsalicylate), can cause serious blood flow problems in the baby if used during the last third of pregnancy (after 28 weeks). Also, aspirin may increase the chance for bleeding problems in the mother and the baby during pregnancy or at delivery.

The labels for nicotine therapy
drugs, like the nicotine patch and lozenge, remind women that smoking can harm an unborn child. While the medicine is thought to be safer than
smoking, the risks of the medicine are not fully known. Pregnant smokers are told to try quitting without the medicine first.